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Laboratory Management; Quality Assurance/Control
Expert has demonstrated expertise with the design, development, and start-up of laboratory facilities. These facilities have been used for analytical testing, physical characterization, environmental sample conditioning, and drug stability testing. He has specified and implemented purified water systems, sample conditioning…
Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Retail Computer Systems, Supply Chain Software, Forecasting and Ordering Software, Promotions
INVENTORY CONTROL SYSTEM; INVENTORY MANAGEMENT. Expert has served the retail industry as a consultant, lecturer, author, marketer, and systems specialist since 1977. Throughout this period, Expert has been involved with the development and marketing of leading-edge solutions. She has continually…
Statistical Analysis, Market Research, Clinical Trials,Marketing Mix Models,Pharmaceuticals,DOE
CLINICAL TRIAL: Expert has over 20 years experience in the statistical design and analysis of clinical trials of health care products. His experience includes working with both pharmaceutical and over-the-counter products. His recent analytical work has included preparing clinical trial…
Fluorescence Spectroscopy, Analysis of Metal Ions by Chelation with Organic Ligands, etc.
FLUORESCENCE SPECTROSCOPY. Expert has worked in the area of fluorescence spectroscopy for almost thirty years. He has published extensively on the influences of pH and solvent composition upon fluorescence spectra and has used these phenomena to study the rates and…
Bioprosthesis, Cardiac Valves, Biocompatible Materials, Cardiovascular Diseases, Biomedical Eng.
BIOMEDICAL ENGINEERING. Expert has expertise in biomedical engineering, particularly in the areas of prosthetics and implantable devices. HEART VALVE PROSTHESIS; CARDIAC VALVE. The bulk of Expert's research has been related to heart valve prosthesis. His work has focused on the…
Mass Spectrometry, HPLC/MS, Ion Trap MS, LC/MS/MS in Environmental, Food, Proteomic, and Pharmaceutical Analysis
Expert has been hired by law firms as an expert witness in the area of analytical chemistry. He has worked with 15 law firms in his career, with some of the cases going over multiple years. This experience includes: •…
Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management
Records Management; Document Management; Electronic Records: For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and writer. He has extensive experience developing information and records management policies, strategic…
Physical Chemistry of Food & Drugs
FOOD CHEMISTRY; FOOD DRYING. Expert is a recognized authority in the physical chemistry of the stability of dry and semi-moist systems including foods, drugs, and biologies. His major research areas deal with the effect of temperature and are properties of…